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A Study of CIN-107 in Patients With Uncontrolled Hypertension

NCT05137002 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2023-08-01

Study results available
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Summary

This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with uncontrolled hypertension. The primary objective was to demonstrate that treatment with baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were hypertensive despite taking one or two anti-hypertensive medications.

Participants were assigned to take placebo or baxdrostat once per day for 8 weeks while they continued taking the regular anti-hypertensive medications. At the end of the 8-week period, qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for 4 weeks while they discontinued taking the background anti-hypertensive medication.

Conditions

Interventions

DRUG

CIN-107

CIN-107 tablets by mouth once daily

DRUG

Placebo

Placebo tablets by mouth once daily

Sponsors & Collaborators

  • CinCor Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2022-09-13
Completion
2022-10-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05137002 on ClinicalTrials.gov